UNK Saline Implant
Received Jul 27, 2026
Report 9617229-2026-13968 · MDR key 50000737
Device
Generic name
Prosthesis, Breast, Inflatable, Internal, Saline
Manufacturer
Allergan (costa Rica)Catalog number
UNK Saline Implant
Product problems
- Fluid/Blood Leak
- Device Appears to Trigger Rejection
Patient
Not reported
- Capsular Contracture
Narrative
Description of Event or Problem
Healthcare professional reported "Deflation, and capsular contracture Baker grade unknown". This record is for the right side. The device has been explanted.
Additional Manufacturer Narrative
The event of "Capsular Contracture" is a physiological complication and analysis of the device generally does not assist Allergan in determining a probable cause for this event.Further information from the reporter regarding event, product, or patient details has been requested. No additional information is available at this time.Reason for reoperation: Deflation and Capsular Contracture, Baker grade unknown.